A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
The purpose of this study is to evaluate the safety and clinical activity of tislelizumab (an anti-PD-1 antibody) in combination with SX-682 (a CXCR1/2 inhibitor) in subjects with newly diagnosed and surgically resectable pancreatic adenocarcinoma.
Conditions:
🦠 Pancreatic Cancer
πŸ—“οΈ Study Start (Actual) 8 November 2023
πŸ—“οΈ Primary Completion (Estimated) September 2026
βœ… Study Completion (Estimated) September 2026
πŸ‘₯ Enrollment (Estimated) 25
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE2
Locations:
πŸ“ Baltimore, Maryland, United States

πŸ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * Ability to understand and willingness to sign a written informed consent document.
    • * Age β‰₯18 years.
    • * Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas.
    • * Tumor must be resectable.
    • * Patient's acceptance to have a tumor biopsy.
    • * ECOG performance status 0 or 1
    • * Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
    • * For both Women and Men, must use acceptable form of birth control while on study.

    Exclusion Criteria:

    • * Have received any anti-pancreatic cancer therapy.
    • * Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study.
    • * Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
    • * Subjects with active, known or suspected autoimmune disease that may relapse.
    • * Systemic steroid therapy (\> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
    • * Active infection requiring systemic therapy.
    • * Infection with HIV or hepatitis B or C at screeningβ€’
    • * History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
    • * Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
    • * Prior allogeneic stem cell transplantation or organ transplantation
    • * Any major surgical procedure requiring general anesthesia ≀ 28 days before first dose of study drug.
    • * Have received a live vaccine ≀ 28 days before first dose of study drug.
    • * Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.
    • * ECG demonstrating a QTc interval β‰₯ 470 msec or patients with congenital long QT syndrome.
    • * Severe hypersensitivity reaction to any monoclonal antibody.
    • * Concurrent participation in another therapeutic clinical study
    • * Pregnant or breastfeeding
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 October 2022
  • First Submitted that Met QC Criteria 28 October 2022
  • First Posted 3 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 March 2024
  • Last Update Posted 15 March 2024
  • Last Verified March 2024